Dexmedetomidine in Topical Versus Peribulbar Anesthesia for Cataract Surgery

Kafrelsheikh University

Status and phase: Enrolling; Phase 2

Conditions: Peribulbar; Dexmedetomidine; Cataract Surgery; Anesthesia

Treatments: Drug: Topical dexmedetomidine; Drug: Reginal dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05692167

MKSU 50-11-3

Details and patient eligibility

About

The aim of this study is to compare efficacy of dexmedetomidine as an additive to topical versus peribulbar anesthesia for cataract surgery

Full description

Ocular surgery may be performed under topical, regional, or general anesthesia. The first recorded use of regional anesthesia for surgery was the instillation of cocaine into the conjunctival sac in 1884 by an Austrian ophthalmologist.

Davis and Mandel in 1986 described the peribulbar block, peribulbar block has delayed onset and need a higher volume of local anesthetic (LA) than a retrobulbar block. But the peribulbar block is away from intra-conal space and so produce fewer complication.

Dexmedetomidine is used as adjuvant to LA drugs in peripheral nerve block, brachial plexus block and intrathecal anesthesia with satisfactory results. A more recent study using dexmedetomidine (50 μg) with the peribulbar block before cataract surgery demonstrated an IOP decrease similar to IV dexmedetomidine administration and greater than a peribulbar block without dexmedetomidine.

Enrollment: 94 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists (ASA) physical status classification I or II who scheduled for eye surgery

Exclusion criteria

• Patients who are younger than 18 years
• The usual contraindications for regional anesthesia such as patients refusing LA
• Clotting abnormalities
• Impaired mental status
• Allergy to any of the study medications
• patients had the severe cardiac disease
• chronic obstructive lung disease and a history of sleep apnea
• contraindications to the use of dexmedetomidine
• history or significant cardiovascular disease risk factors
• significant coronary artery disease or any known genetic predisposition
• history of any kind of drug allergy
• drug abuse
• psychological or other emotional problems
• special diet or lifestyle
• clinically significant abnormal findings in physical examination
• electrocardiographic (ECG) or laboratory screening
• known systemic disease requiring the use of anticoagulants.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Topical dexmedetomidine group

Active Comparator group

Description:

Patients will receive mixture of one milliliter of dexmedetomidine-HCl and local anesthetic

Treatment:

Drug: Topical dexmedetomidine

Reginal dexmedetomidine group

Active Comparator group

Description:

Patients will receive mixture of bupivacaine 0.5% (4.5 ml) + lidocaine 2% (4.5 ml) + dexmedetomidine 50 μg (1 ml) in peribulbar block

Treatment:

Drug: Reginal dexmedetomidine